- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04014517
Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients (EPIRIC)
November 25, 2019 updated by: Istituto Clinico Humanitas
This is an interventional randomized ope-label two-arm trial on the peri-operative use of immunonutrition in Crohn's Disease (CD) patients undergoing colorectal elective surgery.The aim of the trial is to assess the effectiveness of immunonutrition therapy in decreasing the rate of post-operative infective complications and 6 months endoscopic disease recurrence.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Crohn's Disease (CD) patients undergoing abdominal surgery are at high risk to develop post-operative surgical and medical infective complications.
Infective complications affect almost 24% of patients.
Post-surgical disease recurrence afflicts 35-85% of CD patients in the first year after surgery.
Immunonutrition has been successfully applied to surgical patients in several randomized trials, demonstrating a decreased rate of post-operative infective complications.
The aim of the study is to compare the incidence of surgical and medical post-operative infective complications and six months endoscopic and clinical disease recurrence (DR) in CD patients receiving immunonutrition in the peri-operative setting compared to patients treated as for standard of care.
Study Type
Interventional
Enrollment (Anticipated)
350
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Annalisa Maroli, PhD
- Phone Number: +390282247776
- Email: annalisa.maroli@humanitas.it
Study Contact Backup
- Name: Lara Monti, MS
- Phone Number: +390282244623
- Email: lara.monti@humanitas.it
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients > 18 years old, females or males;
- Established Crohn's Disease at the time of surgery indication;
- Patients scheduled for elective open or minimally invasive bowel resection or strictureplasty;
- Patients planned for concomitant perianal surgery for CD-related perianal disease can be included in the study.
Exclusion Criteria:
- Patients < 18 years old;
- Pregnant or breastfeeding women;
- Diagnosis of undetermined colitis;
- Concomitant diagnosis of malignancy;
- Established malnutrition, according to clinical definition, requiring nutritional intervention;
- Patients with more than two criteria for high risk of recurrence among the following: previous abdominal resection, penetrating disease phenotype or active smoking;
- Any condition that, in the opinion of the investigator, can interfere with the consent procedure or the conduction of the trial;
- Patients known to have allergic history to any component of the investigational product;
- Patient with liver and kidney dysfunction (alanine aminotransferase ALT ≥ 2 times the upper limit of normal; total bilirubin TBIL ≥ 2 times the upper limit of normal; creatinine Cr ≥ 2 times the upper limit of normal);
- Patients diagnosed with diabetes or fasting blood glucose≥ 10mmol/L;
- Planned recovery shorter than 48 hours;
- Surgery in emergency setting;
- Any concomitant surgery not related to CD or perianal CD.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard of Care
Standard of Care is represented by the best standard peri-operative treatment already planned for the study population: as for ERAS guidelines, it is represented by fast restoration of liquid and solid diet after surgery (approximately 24 hours after surgery) and pre-operative and post-operative dietary counselling whenever indicated by the surgeon or gastroenterologist
|
Standard of Care is represented by the best standard peri-operative treatment already planned for the study population: as for ERAS guidelines, it is represented by fast restoration of liquid and solid diet after surgery (approximately 24 hours after surgery) and pre-operative and post-operative dietary counselling whenever indicated by the surgeon or gastroenterologist
|
Experimental: Immunonutrition
Impact
|
Impact.
Patients will be asked to consume 3 cartons/day of Nestle IMPACT for pre-operative 7 days and 1 carton/day of Nestle IMPACT for post-operative 30 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative infective complications rate
Time Frame: 30 days post-operatively
|
Post-operative infective complications rate (including intra-abdominal septic complications, surgical site infections and medical inflections) will be evaluated with clinical, radiological and molecular analysis
|
30 days post-operatively
|
6 months endoscopic recurrence
Time Frame: 6 months post-operatively
|
Endoscopic recurrence will be evaluated through colonoscopy with or without biopsies and Rutgeert score.
Rutgeert score is an endoscopic risk score intended to predict disease recurrence: it is calculated depending on the number and type of intestinal lesions and consists of five level of disease recurrence risk, from 0 (endoscopic remission) to 4 (advanced disease recurrence).
|
6 months post-operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6 months nutritional status
Time Frame: 6 months post-operatively
|
Nutritional status will be evaluated through the Malnutrition Universal Screening Tool (MUST).
MUST consists of three different levels, generating a risk predictor ranging from 0 (low risk) to 2 (high risk), considering the calculated Body Mass Index (BMI), the unintentional weight loss and the pathological conditions of the patient.
|
6 months post-operatively
|
30 days quality of life
Time Frame: 30 days post-operatively
|
Quality of Life will be evaluated trhough the Short-Inflammatory Bowel Disease Quality of Life questionnaire (S-IBDQoL), which is 10-item questionnaire.
All items are reported in a 7 point scale, from "all of the time" to "none of the time" (1 = poor health; 7 = good health).
|
30 days post-operatively
|
90 days quality of life
Time Frame: 90 days post-operatively
|
Quality of Life will be evaluated trhough the Short-Inflammatory Bowel Disease Quality of Life questionnaire (S-IBDQoL), which is 10-item questionnaire.
All items are reported in a 7 point scale, from "all of the time" to "none of the time" (1 = poor health; 7 = good health).
|
90 days post-operatively
|
6 months quality of life
Time Frame: 6 months post-operatively
|
Quality of Life will be evaluated trhough the Short-Inflammatory Bowel Disease Quality of Life questionnaire (S-IBDQoL), which is 10-item questionnaire.
All items are reported in a 7 point scale, from "all of the time" to "none of the time" (1 = poor health; 7 = good health).
|
6 months post-operatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2020
Primary Completion (Anticipated)
March 1, 2022
Study Completion (Anticipated)
October 1, 2022
Study Registration Dates
First Submitted
July 8, 2019
First Submitted That Met QC Criteria
July 8, 2019
First Posted (Actual)
July 10, 2019
Study Record Updates
Last Update Posted (Actual)
November 27, 2019
Last Update Submitted That Met QC Criteria
November 25, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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